Trial · NCT00912964
Outcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 12 | The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized. | Incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition | Baseline and Week 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized. | mL | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | Baseline and Week 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4 | The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was not utilized in this analysis. | Incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency | Baseline and Week 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Week 12 | The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode at baseline. Last observation carried forward (LOCF) was utilized. | urgency incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Baseline and Week 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. Last observation carried forward was utilized. | urgency episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Baseline and Weeks 8 and 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as N. LOCF was not used in this analysis. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Weeks 8 and 12 | The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as N. LOCF was not utilized. | Incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Baseline and Weeks 4, 8 and 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as N. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode (grade 3 or 4) at baseline. LOCF was not utilized. | Urgency incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was not utilized for this analysis. N is the number of patients included at each time point. | Urgency episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency | Baseline and Weeks 4, 8 and 12 | The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized for this analysis. The number of participants included in the calculation for each time point is noted as N. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point. | nocturia episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point. | pads | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Weeks 4, 8 and 12 | The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Baseline and Weeks 4, 8 and 12 | The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders for Mean Level of Urgency | Baseline and Week 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes | Baseline and Week 12 | The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00912964/outcomes